Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485498
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 11, 2007
June 11, 2007
April 2003
Not Provided
To determine if the efficacy of oral dose of olanzapine is greater than oral dose of risperidone in acute schizophrenia by comparing changes in agitation from baseline to 3 days post-first oral dose
Same as current
No Changes Posted
  • To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 3 days as measured by the BPRS-T, PANSS-P, ACES, CGI-I and CGI-S.
  • To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the BPRS-T
  • To assess the efficacy of olanzapine compared with risperidone, in reduction of scores from baseline to 6 weeks of acute treatment in the PANSS
  • To compare the change in severity of akathasia in schizophrenic patients between olanzapine and risperidone as measured by the BAS within the 6-week treatment period
  • To compare the change of severity of extrapyramidal symptoms within the 6 week treatment with olanzapine and risperidone, as measured by the SAS
Same as current
Not Provided
Not Provided
 
Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics
Managing Acute Schizophrenia, a Double Blind Comparison Between Two Atypical Antipsychotics - Olanzapine and Risperidone

The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
  • Drug: Olanzapine Hydrochloride
  • Drug: Risperidone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
December 2003
Not Provided

Inclusion Criteria:

  • Male or female subjects, aged 18 - 60
  • Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
  • Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
  • BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
  • Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications

Exclusion Criteria:

  • Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
  • Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
  • Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
  • Treatment with remoxipride within 6 months (180 days) prior to visit 1
  • Documented history of allergic reaction to study medications
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00485498
6704, F1D-GH-S036
Not Provided
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP